ADACEL SUMMARY
Adacel®, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.
Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age.
The use of Adacel vaccine as a primary series, or to complete the primary series, has not been studied.
Vaccination with Adacel vaccine may not protect all of vaccinated individuals.
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NEWS HIGHLIGHTS
Published Studies Related to Adacel (Tetanus Diphtheria Pertussis Vaccine)
An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children. [2011.06.06]
Tetravalent meningococcal serogroups ACWY conjugate vaccines will provide an advantage to those at most risk of invasive meningococcal disease; namely young children. Co-administration of ACWY-TT with DTaP-HBV-IPV/Hib was assessed in a randomized trial in 793 children aged 12-23 months.ACWY-TT and DTaP-HBV-IPV/Hib co-administration during the second year would facilitate introduction of ACWY-TT into routine toddler vaccination schedules.
Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. [2011.06]
BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 mug Hansenula polymorpha-derived recombinant hepatitis B (Hep B) surface antigen, Sanofi Pasteur, in Argentinean infants... CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) is highly immunogenic and safe when compared with licensed comparators, warranting further development.
Immunogenicity and safety of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus type b conjugate vaccine when administered concurrently with a pneumococcal conjugate vaccine: a randomized, open-label, phase 3 study. [2011.03.03]
A phase 3 randomized, multicenter study evaluated the safety and immunogenicity of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus influenzae type b conjugate vaccine (DTaP(5)-IPV/Hib) administered at the same visit with 7-valent pneumococcal conjugate vaccine (PCV7, concurrent group) or at separate visits (separated by >/= 15 days; staggered group).
Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China. [2011.02.24]
The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim((R))) compared to individual vaccines in infants in the People's Republic of China. Infants (N=792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib((R))) and IPV (Imovax((R)) Polio) at 3, 4 and 5 months of age (Group C)...
Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the Republic of Korea. [2011.02.11]
This randomized trial enrolled 442 infants in the Republic of Korea to assess the immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV; Tetraxim) for primary vaccination at 2, 4 and 6 months of age compared with DTaP and IPV vaccines given separately.
Clinical Trials Related to Adacel (Tetanus Diphtheria Pertussis Vaccine)
Post Marketing Surveillance for ADACEL™ in South Korea [Recruiting]
This safety surveillance study is being conducted in accordance with Korea Food and Drug
Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new
drug".
The study objective is to assess within 30 days post-administration, the safety of ADACEL™
administered under the real clinical practice.
Pertussis Maternal Immunization Study [Recruiting]
The purpose of this study is to assess whether immunization against pertussis in the mid
third trimester of pregnancy provides passive protection to the infant by transfer of IgG
transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk,
sufficient to protect the infant against pertussis disease in the critical neonatal period,
without suppressing the infant's immune response to active immunization and disease
Reports of Suspected Adacel (Tetanus Diphtheria Pertussis Vaccine) Side Effects
Incorrect Route of Drug Administration (5),
Erythema (3),
Fatigue (3),
Pertussis (3),
Inflammation (3),
Open Wound (3),
Cough (3),
Blister (3),
Vaccination Failure (3),
Nasal Congestion (3), more >>
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Page last updated: 2011-12-09
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